Postoperative Complications4CRT_AneNCT03697057
4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia
An observational study of Postoperative Complications, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The recovery of patients after general anaesthesia is usually estimated by using clinical signs and scores. Since there is a lack of the agreed objective methods for assessing cognitive and psychomotor recovery after general anaesthesia in ambulatory settings, the aim of this study was to evaluate three psychological… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- General anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 166 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Consecutive patients scheduled for ambulatory gynaecologic surgery were asked to participate in the study during the routine informed consent process for anaesthesia. The inclusion criteria are listed in previous Section. A group of healthy female volunteers, meeting the eligibility criteria, completed the same study procedure without a surgery at three matched time points; none of them was taking any medication at the time of the study. Written informed consent was obtained from all individuals.
Who may be able to join
- consecutive patients scheduled for ambulatory gynaecologic surgery
- age of 18 to 60 years
- a physical status I-II according to American Society of Anesthesiologists (ASA) classification
- fluency in German language and the ability to perform all tests
Who cannot join
- chronic consume of analgesics, psychotropic drugs, sedatives or alcohol
- if the ambulatory surgery lasted more than 60 minutes
- if the schema of standardised general anaesthesia was changed
- if the ambulatory setting was changed and the patients unexpectedly remained over night in the hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computerised 4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia
The recovery of patients after general anaesthesia is usually estimated by using clinical signs and scores. Since there is a lack of the agreed objective methods for assessing cognitive and psychomotor recovery after general anaesthesia in ambulatory settings, the aim of this study was to evaluate three psychological tests for this purpose. Patients, who were scheduled for ambulatory gynaecological surgery, underwent 3 standard psychological tests before (T1), 15 minutes after the surgery (T2) and on discharge from the recovery room (T3). The tests used were Wechsler memory scale (test 1, working memory capacity), d2 - test (test 2, concentration endurance) and computer-based 4-choice-reaction time (4CRT, test 3, reaction time) as well as Postanesthesia Discharge Scoring System (PADSS). The same test battery was used in healthy female volunteers, all test results were compared at the different time points.
- Conditions
- Postoperative Complications
- Being tested
- General anaesthesia
- Keywords
- postoperative recovery, psychomotor function, measurement
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anaesthesiaProcedure or surgery
Standard general anaesthesia for gynecologic surgery in patient group
| Study group | Role | What they receive |
|---|---|---|
| patients | Patients scheduled for elective ambulatory gynaecological surgery, which was performed under standardised general anaesthesia Receives: Procedure: General anaesthesia | |
| healthy volunteers | Female healthy volunteers matched to the patient group regarding the age |
What is being measured
The primary outcome is the main question the study is designed to answer.
4CRT_15_min
Change of four choice reaction time (4CRT) at 15 minutes after surgery from baseline
Measured: 15 minutes after the end of surgery
Secondary outcomes (1)
PADSS (Patient Discharge Scoring System)
Post Anaesthetic Discharge Scoring System (PADSS) is a clinically-based, objective scoring system used to measure the home readiness of patients following day surgery. PADSS consists of six criteria: ambulation, circulation (blood pressure monitoring), nausea/vomiting, pain and surgical bleeding bleeding. Each criterion is given a score ranging from 0 to 2, maximal score is 10. Only patients who achieve a score of 9 or more are considered ready for discharge.
Measured: Measured 60 minutes after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study startMar 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Hesse, MD, Principal investigator, University Medicine of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697057
- Sponsor's protocol ID
- III UV 03/05
- Acronym
- 4CRT_Ane
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will send the IPD on request via email.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerised 4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia
- ClinicalTrials.gov ID
- NCT03697057
- Acronym / sponsor ID
- 4CRT_Ane / III UV 03/05
- Conditions
- Postoperative Complications
- Keywords
- postoperative recovery, psychomotor function, measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Mar 2008 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The recovery of patients after general anaesthesia is usually estimated by using clinical signs and scores. Since there is a lack of the agreed objective methods for assessing cognitive and psychomotor recovery after general anaesthesia in ambulatory settings, the aim of this study was to evaluate three psychological tests for this purpose. Patients, who were scheduled for ambulatory gynaecological surgery, underwent 3 standard psychological tests before (T1), 15 minutes after the surgery (T2) and on discharge from the recovery room (T3). The tests used were Wechsler memory scale (test 1, working memory capacity), d2 - test (test 2, concentration endurance) and computer-based 4-choice-reaction time (4CRT, test 3, reaction time) as well as Postanesthesia Discharge Scoring System (PADSS). The same test battery was used in healthy female volunteers, all test results were compared at the different time points.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | Procedure: General anaesthesiaPatients scheduled for elective ambulatory gynaecological surgery, which was performed under standardised general anaesthesia |
| healthy volunteers | – | –Female healthy volunteers matched to the patient group regarding the age |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Consecutive patients scheduled for ambulatory gynaecologic surgery were asked to participate in the study during the routine informed consent process for anaesthesia. The inclusion criteria are listed in previous Section. A group of healthy female volunteers, meeting the eligibility criteria, completed the same study procedure without a surgery at three matched time points; none of them was taking any medication at the time of the study. Written informed consent was obtained from all individuals.
Key inclusion criteria (4 listed)
- consecutive patients scheduled for ambulatory gynaecologic surgery
- age of 18 to 60 years
- a physical status I-II according to American Society of Anesthesiologists (ASA) classification
- fluency in German language and the ability to perform all tests
Key exclusion criteria (4 listed)
- chronic consume of analgesics, psychotropic drugs, sedatives or alcohol
- if the ambulatory surgery lasted more than 60 minutes
- if the schema of standardised general anaesthesia was changed
- if the ambulatory setting was changed and the patients unexpectedly remained over night in the hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anaesthesiaStandard general anaesthesia for gynecologic surgery in patient group | Procedure or surgery | patients |
Primary outcome
4CRT_15_min
Time frame: 15 minutes after the end of surgery
Change of four choice reaction time (4CRT) at 15 minutes after surgery from baseline
1 secondary outcome
PADSS (Patient Discharge Scoring System)
Time frame: Measured 60 minutes after the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No. We will send the IPD on request via email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Hesse, MD principal investigator
University Medicine of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4CRT_15_min (time frame: 15 minutes after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.